Multiple Myeloma Clinical Trial

Improving Cognitive Function in Older Adults Undergoing Stem Cell Transplant

Summary

Cancer and treatment-related cognitive changes hinder resumption of normal routine and roles and worsen quality of life. Older adults undergoing hematopoietic cell transplantation (HCT) are at high-risk for cognitive impairment. Physical activity improves cognitive function in older adults and survivors of other cancers. We hypothesize that increasing physical activity can also improve cognitive function in this vulnerable population. The objective of this research is to adapt and test an evidence-based physical activity intervention, The Community Health Activities Model Program for Seniors II (CHAMPS II), in the HCT setting for adults 60 years and older.

Aim 1: Adapt the CHAMPS-II manual and develop study materials using feedback from 10 patient/care-partner dyads who have experienced the HCT process within the last 3-6 months and HCT team members via semi-structured interviews. Aim 2: Iteratively adapt and implement CHAMPS-II intervention in three waves (2-4 patient/care-partner dyads per wave). The dyads will participate in a multi-phase, light to moderate-intensity physical activity program through Day 100 post-HCT. Aim 3: Test the preliminary effectiveness of the adapted intervention to improve cognitive function compared to an active control condition (N = 34 per group) in a 2-arm, pilot randomized controlled trial.

Primary and secondary outcomes will include subjective and objective cognitive function using a short battery of neuropsychological tests and a self-report questionnaire. Tertiary outcomes comprise subjective and objective measures of physical activity behavior and physical function. The RE-AIM framework will be utilized for formative and process evaluation during the adaptation process and implementation of the intervention.

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Full Description

Hematologic malignancies are diseases that primarily affect older adults, with a median age at diagnosis of 65 years. Hematopoietic cell transplantation (HCT) is a potentially curative and life-prolonging treatment for patients with hematologic malignancies. Cancer and treatment-related cognitive changes cause distress, hinder resumption of normal routine and roles, and worsen quality of life. HCT differs from the delivery of chemotherapy in other cancer settings due to the intensity of chemotherapy and severity of toxicity. Older adults undergoing HCT are at high risk for cognitive decline and pervasive cognitive deficits. Interventions to improve cognitive outcomes are needed. The prevalence and risk of cognitive decline post-HCT are greater for older adults because of a greater number of existing health conditions (i.e., vascular disease) and impaired physical and psychologic function pre-HCT that can be exacerbated by treatment and the overall HCT experience.

Exercise training improves cancer-related health outcomes, including cardiorespiratory fitness, inflammation, cancer related fatigue, depressive symptoms, and sleep disturbance. There is consistent evidence showing that physical activity improves cognitive function in older adults and survivors of other cancers. Improvement in cardiorespiratory fitness, brain structure, and inflammation underlie the mechanisms of the cognitive benefits of physical activity. While untested in older adults undergoing HCT, the investigator hypothesizes that increasing physical activity can also improve cognitive function in this vulnerable population.

Physical activity improves the cognitive domains most affected by cancer treatment, namely executive function and working memory. Cognitive function is an important outcome to older adults and has not been a focus of physical activity interventions in the HCT population. In addition, older adults are underrepresented in previous physical activity interventions in the HCT population.

The researcher will adapt CHAMPS II, an evidence-based physical activity intervention, to the HCT setting for older adults to improve cognitive function. CHAMPS II increased physical activity in sedentary older adults with multiple chronic health conditions. This is an individually tailored program that provides information, skills, training, and problem-solving support to older adults. The program provides a foundation for application by including an instructor manual and directions for implementation. CHAMPS-II has been adapted and implemented in diverse communities using existing resources and improving contextual factors to increase physical activity for sedentary older adults.

Adaptation of evidence-based interventions, such as CHAMPS-II, can result in an attenuation of effects if the core components are not maintained. However, adaptations can be made to fit the needs and priorities of the service setting, target audience, mode of delivery, and cultural context without compromising CHAMPS-II effectiveness. Through a research-practice partnership approach, the research team will help adapt the program while maintaining the core components of CHAMPS-II, develop new program materials, provide training, monitor implementation, and conduct program evaluation. The overarching goal is to enable HCT team members to implement CHAMPS-II and leverage existing organizational resources to enhance feasibility and sustainability.

The research plan proposes a hybrid effectiveness-implementation design, which is a design that spans the effectiveness and implementation research to accelerate the translation of physical activity interventions into practice for older adults with cancer. This novel trial design will allow testing of the program within a randomized clinical trial methodology while observing and gathering information on implementation. The effectiveness study condition offers an ideal opportunity to examine implementation issues and plan for implementation strategies for a future study that examines both effectiveness and implementation strategies. The study will use the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework for planning and formative and process evaluation of the intervention. Formative and process evaluation provides information needed to evaluate an intervention's potential for translation into clinical practice.

View Eligibility Criteria

Eligibility Criteria

Arm 1:

Inclusion Criteria for Participants:

age 60 years and older
have a diagnosis of hematological malignancy
have received autologous or allogeneic HCT within the prior 3-6 months
able to speak and read English
have provided written informed consent

Exclusion Criteria for Participants:

there are no exclusion criteria

Inclusion Criteria for Participants' Care-Partner:

age 19 years and older
able to speak and read English

Exclusion Criteria for Participants' Care-Partner:

there are no exclusion criteria

Inclusion Criteria for Transplant Team Member:

age 19 years and older
able to speak and read English

Exclusion Criteria for Transplant Team Member:

there are no exclusion criteria

Arms 2 and 3:

Inclusion Criteria for Participants:

age 60 years and older
have a diagnosis of hematological malignancy
planned to receive an autologous or allogeneic HCT
able to walk 4 meters as part of the Short Physical Performance Battery (with or without assistance)
(In Arm 3 only): willingness to be randomized to either the physical activity intervention or survivorship education active control condition, and to follow the protocol for the group to which they have been assigned
able to speak and read English
have provided written informed consent

Exclusion Criteria for Participants:

development of chest pain, severe shortness of breath, or occurrence of other safety concerns during the physical performance measures (i.e. Short Physical Performance Battery)
is not cleared to participate in exercise by a physician

Individuals with the following current conditions/diagnoses documented in medical history will be required to provide clearance for exercise from their cardiologist:

Myocardial infarctions in the past 3 months
Resting or unstable angina
Uncontrolled and/or serious arrhythmias
3rd degree heart block
Acute congestive heart failure or ejection fraction <30%
Clinically significant aortic stenosis

Individuals with the following conditions/diagnoses will be required to provide clearance for exercise from their surgeon:

o Hip fracture, hip or knee replacement, or spinal surgery in the past 3 months

other medical, psychiatric, or behavioral factors that in the judgement of the principal investigator may interfere with study participation or the ability to follow either the intervention or the active control condition

Inclusion Criteria for Participants' Care-Partner:

age 19 years and older
able to speak and read English
able to walk 4 meters as part of the Short Physical Performance Battery (with or without assistance)
have no medical contraindications for participating in light to moderate-intensity physical activity per PI review of medical history as reported on the care-partner medical history form

Exclusion Criteria for Participants' Care-Partner:

development of chest pain, severe shortness of breath, or occurrence of other safety concerns during the physical performance measures (i.e. Short Physical Performance Battery)
is not cleared to participate in exercise by a physician

Individuals with the following current conditions/diagnoses documented in medical history will be required to provide clearance for exercise from their cardiologist:

Myocardial infarctions in the past 3 months
Resting or unstable angina
Uncontrolled and/or serious arrhythmias
3rd degree heart block
Acute congestive heart failure or ejection fraction <30%
Clinically significant aortic stenosis

Individuals with the following conditions/diagnoses will be required to provide clearance for exercise from their surgeon:

o Hip fracture, hip or knee replacement, or spinal surgery in the past 3 months

other medical, psychiatric, or behavioral factors that in the judgement of the principal investigator may interfere with study participation or the ability to follow either the intervention or the active control condition

Inclusion Criteria for Transplant Team Member:

age 19 years and older
able to speak and read English

Exclusion Criteria for Transplant Team Member:

there are no exclusion criteria

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

90

Study ID:

NCT04898790

Recruitment Status:

Recruiting

Sponsor:

Thuy Koll MD

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There is 1 Location for this study

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University of Nebraska Medical Center
Omaha Nebraska, 68198, United States More Info
Thuy Koll, MD
Contact
402-559-7519
[email protected]
Marcia Free, RN
Contact
402-552-7623
[email protected]
Thuy Koll, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

90

Study ID:

NCT04898790

Recruitment Status:

Recruiting

Sponsor:


Thuy Koll MD

How clear is this clinincal trial information?

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